The U.S. Food and Drug Administration (FDA) has approved Tazverik (tazemetostat) to treat persons 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection.
Epithelioid sarcoma is a rare form of soft tissue sarcoma that often occurs in young adults.
It is an aggressive cancer that usually begins in the soft tissue under the skin of an extremity, but it can start anywhere. If the cancer is localized, surgery is the primary treatment option but, in many cases, the cancer spreads and other treatment options are needed. The average survival rate for this cancer after it spreads is about 10 to 16 months.
In a news release, Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence said, “Epithelioid sarcoma accounts for less than one percent of all soft tissue sarcomas,” adding “Until today, there were no treatment options specifically for patients with epithelioid sarcoma. The approval of Tazverik provides a treatment option that specifically targets this disease. When we brought Tazverik’s application to the Oncologic Drugs Advisory Committee last month, the committee voted unanimously that the benefits of the drug outweighed the risks.”
Tazverik is an EZH2 methyltransferase inhibitor that may attenuate cancer cell growth.
Tazverik’s was given an accelerated approval based on results of a phase 2 clinical trial in which 15% of the patients taking the drug showed an overall response (1.6% had a complete response and 13% had a partial response). Six of the nine patients who did show a response, had a response lasting six months or longer. Gary K. Schwartz, MD, chief of hematology and oncology at Columbia University, and an investigator in the Phase 2 trial said, “The Tazverik data from the ES (epithelioid sarcoma) cohort in Epizyme’s Phase 2 trial support its potential to provide clinically meaningful and durable responses, and tolerability for ES patients. This approval of Tazverik represents an important advancement in the treatment of patients with ES.”
The most common side effects were pain, fatigue, nausea, decreased appetite, vomiting and constipation. Since the drug was granted Accelerated Approval, further clinical trials will likely be necessary to confirm the safety and efficacy of the drug. In the meantime, the developers of Tazverik plan, Epizyme, plan to have the medicine available within 10 business days for patients with epithelioid sarcoma.
To learn more about this and other rare cancers, visit checkrare.com/diseases/rare-cancers/
